Project Manager – AI/ML, Senior
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Job Description
Lead cross-functional execution of AI use cases in quality and CMC sectors for ensuring compliance. Develop scalable AI solutions in regulated environments for Mollica IT.
Responsibilities:
- Lead end-to-end delivery of AI-based digital initiatives in Quality and CMC (Chemistry, Manufacturing and Controls);
- Drive cross-functional execution of AI use cases, ensuring alignment among Digital, Quality, Regulatory, Manufacturing and Data Science teams;
- Translate business needs into scalable AI solutions compliant with regulated environments (GxP);
- Manage technical dependencies, governance, risks and value realization of initiatives;
- Lead complex AI programs from ideation through deployment and scale;
- Develop and manage roadmaps, milestones, risks and KPIs;
- Coordinate multifunctional teams (Data Science, IT, Quality, Manufacturing, vendors);
- Ensure alignment with the company’s digital and AI strategy;
- Define high-value use cases (e.g., deviations, CAPA prediction, batch analysis, document intelligence);
- Oversee model lifecycle (data, training, validation and deployment);
- Ensure solutions are scalable, secure and production-ready;
- Implement AI governance frameworks (model validation, explainability, bias monitoring);
- Ensure compliance with regulations (FDA, EMA, GAMP5, CSA);
- Produce documentation for audits and inspections;
- Ensure data integrity standards (ALCOA+);
- Understand corporate systems architecture (LIMS, MES, SAP, Veeva, data platforms);
- Manage integration dependencies between systems;
- Work with cloud, cybersecurity and infrastructure teams;
- Manage technical performance of vendors;
- Identify technical and regulatory risks and act proactively;
- Lead change adoption in Quality and CMC areas;
- Develop communication plans for executive and operational stakeholders;
- Define measurable KPIs (cycle time reduction, deviation reduction, automation);
- Monitor ROI and business impact of initiatives;
- Ensure sustainable scalability of successful pilots;
- Other routine duties of the area.
Requirements:
- Previous experience in Technical Program Management, Digital Transformation or engineering program management;
- Experience leading AI/ML initiatives or advanced analytics;
- Experience in regulated industries (Pharmaceuticals, Biotechnology or Medical Devices);
- Strong understanding of the AI/ML lifecycle and data governance;
- Experience with enterprise platforms (LIMS, MES, SAP, Veeva, etc.);
- Strong stakeholder management skills and executive communication;
- Bachelor’s degree required.
- Preferred: Practical experience with GxP environments and regulatory frameworks;
- Experience with systems integration and enterprise architecture;
- Experience with cloud, security and data platforms;
- Strong results orientation and value measurement (KPIs/ROI).
Benefits:
- Health insurance for employees and dependents with national coverage (Bradesco or Unimed);
- Dental insurance with national coverage;
- Meal Voucher or Food Voucher (employee choice);
- Childcare assistance;
- Life insurance for employees and dependents;
- Gympass for employees and dependents;
- EAP (Employee Assistance Program) offering: Financial Assistance, Legal Assistance, Social Assistance, Psychological Assistance (24/7);
- Discounts and special rates with universities (Mackenzie, SENAC, FIA, FIAP and BBS Business School) and language schools (CNA, Cultura Inglesa, Wizard, CCAA, Indeed);
- Discounts on banking fees and special rates for Itaú and Bradesco;
- Optional payroll-deductible loan (consigned loan);
- Reimbursement program for some external certifications;
- Training: TCS offers remote and in-person training and development platforms in soft skills, technologies and domains covering over 15,000 topics;
- Length-of-service awards: TCS recognizes employees for commitment and loyalty (3, 5 and 10 years and every 5 years thereafter);
- Employee referral bonus for successful hires;
- TCS Fit4life – program to encourage physical exercise for employees, with an agenda of online functional training;
- International opportunities: depending on skills and business needs you may be eligible to apply for positions abroad (within and outside Latin America);
- And others.
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